FDA grants accelerated approval to Vera Therapeutics' Trutakna for IgA nephropathy

The FDA has granted accelerated approval to Trutakna (formerly known as atacicept) from Vera Therapeutics for adult patients with IgA nephropathy, a chronic kidney disease that can progress to renal failure.

The clearance is based on data showing the drug lowers protein levels in urine, a key marker of disease progression. Vera must complete additional trials to confirm clinical benefit and convert the accelerated approval to a standard one, with results expected in the third quarter.

Trutakna will be priced at $425,000 per year, notably higher than Otsuka's Voyxact, which entered the market last year at a wholesale acquisition cost of $390,000. The pricing difference sets the stage for a commercial battle between the two therapies.